Covid-19 Living Data

Trial ChiCTR-OPN-200002958
Publication Cao Y, J Allergy Clin Immun, 2020 (published paper)
Dates: 2020-02-09 to 2020-02-28
Funding: Public/non profit (The Emergency Research Project of Tongji hospital, Emergency Research Project of Tongji hospital of Huazhong University of Science and Technology, Emergency Research Project of Hubei province.)
Conflict of interest: No

Methods
	RCT Blinding: double blinding
	Location : Multicenter / China Follow-up duration (days): 28
Inclusion criteria	(1) met the diagnostic criteria for COVID-19; (2) 18 years or older and younger than 75 years; (3) severe cases. The diagnosis and the illness severity of COVID-19 were defined according to the Chinese management guideline for COVID-19 (version 5.0) and the full translated edition of diagnostic criteria is available in Supplementary Methods section in the Online Repository at www.jacionline.org.
Exclusion criteria	(1) patients with concomitant malignant tumors; (2) patients with severe cardiovascular and metabolic disease that is not medically controlled; (3) patients with a mental or severe psychiatric disorder; (4) patients in need of invasive mechanic ventilation at recruitment; (5) patients who could not guarantee to complete all the scheduled treatment plans and follow-ups; (6) women of child-bearing age with positive pregnancy tests or those in the lactating period; (7) patients whose condition was further complicated with other active infections.
Interventions
	Treatment Ruxolitinib 5 mg orally twice per day
	Control Vitamin C (100mg)
Participants
	Randomized 43 participants (n₁=22 / n₂= 21)
	Characteristics of participants N=43 Mean age : 60.4 24 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=41 Critical: n=0
Primary outcome
	In the register Safety
	In the report Time to clinical improvement, defined as the time from randomization (D0) to an improvement of two points on a seven-category ordinal scale or live discharge from the hospital (Dend)
Documents available	Protocol NR Statistical plan NR Data-sharing stated NR
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to all available versions of the published/pre-print article, the study registry and the protocol, provided by the authors, was used in data extraction and risk of bias assessment. The authors refer to supplementary files in the article. However these files were not available on the journal website (date of search: 2/6/20). In the initial version of the protocol (Jan. 30, 2020) mesenchymal stem cells were to be administered in combination with ruxolitinib in the intervention group. In the updated version (March.8, 2020) it was decided that mesenchymal stem cells were not necessary. The study did not achieve the target sample size specified in the Methods section. The primary outcome indicated in registry does not reflect the primary outcome reported in the paper. Some outcomes reported in the paper were not pre-specified in the registry (e.g., mortality). Time to negative conversion is assessed only in 17 patients who tested positive at baseline. On July 9th, 2020 we received additional information from authors on this study.